Global RWE

Strategy Consulting, Global Market Access and Real-World Evidence on a new level.

Database Studies

We offer to conduct multi-country and country-specific retrospective database studies in several European countries (UK, France, IT, ESP) as well as in the US; in selected countries (mainly GER), we work with our partner Cytel

  • Through our network of database providers, we can conduct both feasibility studies and full database studies

  • Topics covered by our database studies are epidemiology, treatment patterns including assessment of treatment lines, assessment of health care resource use (HCRU) and cost, adherence & persistence analyses, as well as all types of comparative studies

Our USP:

Broad data access – GIPAM can provide guidance on which databases to use based on an extended network of data providers

Advanced analytical capabilities covering aspects such as

  • Identification of rare diseases based on code combinations

  • Identification of treatment lines

  • Several options for doing comparative analyses, including different types of matching and weighting approaches

If feasible based on the policy of the database owners: Our unique GIPAM Study Reporting (GSR) provides clients with live reports on the status of our studies and – at a minimum – descriptive statistics as DAILY updates.

Related Whitepaper & Publications

Linked Database Studies

Linked Database Studies generally use more than one dataset to enrich the number or breadth of available information; they are typically done in two directions

  • Full linked database studies – linked data are used for all data analyses

  • Validation linked data analyses – small, linked datasets are used to validate proxy outcomes that are used for full (non-linked) data analyses

Linked data studies are the preferred study type if single databases do not provide the necessary level of detail

  • Example: Known claims data do not provide clinical data or provide details on results of specific diagnostics tests

GIPAM offers two types of data linkage on a patient level

  • Probabilistic linkage – linkage of data based on patient characteristics using advanced statistical methods

  • Deterministic linkage – linkage of data based on patient identifiers (such as name, birth date, or insurance number)

GIPAM has the unique capability to link existing large datasets, such as German claims data, to various other datasets, such as medical chart review or survey data

Countries with possible linkage are the following

  • Germany: Statutory Health Insurance claims data with all types of primary data

  • UK: CPRD data with HES and SACT data

  • Italy: IT claims data (LHU) with various clinical datasets

Our USP:

Unique capability to link German claims data with other primary datasets

Broad knowledge of European databases and options to link these data with other available databases

Advanced analytical knowledge to analyze linked datasets and to perform if needed, probabilistic linkage

Our unique GIPAM Study Reporting (GSR): Clients get live reports on the status of our studies and – at a minimum – descriptive statistics as DAILY updates

Related Whitepaper & Publications

Medical Chart Reviews

Medical Chart Reviews (MCRs) are an accepted type of data collection, typically recommended if required data are not available in known existing databases

However, MCRs are sensitive to different types of bias / other weaknesses

  • Site selection bias

  • Patient selection bias

  • Other types of bias resulting from the type and scope of data collection

  • Incomplete data

GIPAM developed a unique framework for the preparation and execution of MCRs in GER, UK, Nordic countries, IT, FR, and ESP that includes specific methods to ensure that the above risks are minimized; that also means that GIPAM studies always use appropriate sampling methods by reducing the risk of convenience sampling

GIPAM performs the MCRs with a unique own and validated eCRF infrastructure

Our USP:

Unique knowledge regarding the design of MCRs, including sampling approaches

Our broad network of sites that are immediately available for MCRs, specifically in the oncology area

Own validated eCRF infrastructure

Our unique GIPAM Study Reporting (GSR): Clients get live reports on the status of our studies and – at a minimum – descriptive statistics as DAILY updates

Related Whitepaper & Publications

Patient Preference and Patient Benefit/Risk Studies are used for a variety of reasons

Early qualitative studies: assess the importance of innovative endpoints, getting early insights into unmet needs

Quantitative Patient Preference Studies

  • Demonstrate the importance of different endpoints

  • Demonstrate the patient value of one’s own treatment against the Standard of Care, also including aspects that are not covered in clinical trials

Quantitative Benefit/Risk Studies

  • Demonstrate the overall value of one’s own treatment against other treatments, explicitly taking into account trade-offs (i.e., better efficacy but the increasing probability of mild safety events)

  • Express benefits of specific treatments in widely understood units (such as the number of accepted safety events to gain one additional life year)

    GIPAM offers all types of Patient Preference and Benefit/Risk Studies in regions such as GER, UK, Nordics, Austria, Switzerland, FR, IT, ESP, and the US

  • Extended preparation of studies via lit reviews and expert discussions versus targeted approach

  • Site-based patient inclusion versus panel-based approach

Our USP:

Unique knowledge and framework for planning patient preference/benefit/risk studies

Unique network of sites and panels that can immediately be activated to conduct these studies

Advanced analytical knowledge to analyze preference datasets and to perform, if needed, further analyses such as latent class analysis

Our unique GIPAM Study Reporting (GSR): Clients get live reports on the status of our studies and – at a minimum – descriptive statistics as DAILY updates

Related Whitepaper & Publications

Adherence & Persistence Studies

Adherence to treatment describes the degree a patient implements a prescribed treatment regimen, while persistence refers to the time of therapy continuation.

Adherence and persistence are known to affect the real-world effectiveness and safety of therapies in a decisive way.

GIPAM offers different types of adherence/persistence studies, including database-driven adherence/persistence studies and patient and/or physician surveys, in all major European countries

Our USP:

Unique analysis framework to conduct adherence/persistence analyses based on existing datasets

Network of sites and panels to conduct adherence surveys

Own two questionnaires to conduct adherence surveys:

  • AAQ (Adherence Assessment Questionnaire): assessing the observed degree of non-adherence

  • ABQ (Adherence Barriers Questionnaire): assessing barriers to adherence and classifying a patient according to observed adherence barriers

Our unique GIPAM Study Reporting (GSR): Clients get live reports on the status of our studies and – at a minimum – descriptive statistics as DAILY updates

Related Whitepaper & Publications

Physician Surveys

GIPAM offers different types of physician surveys, covering a wide range of topics

Types

  • Individual discussions

  • Advisory Boards

  • Delphi Panels

  • Broad quantitative surveys

Topics

  • Treatment guidelines and patient pathways

  • Relevance of outcomes, symptoms, etc.

  • Treatment preferences

Our USP:

Unique experience in planning and conducting physician surveys

Analytical knowledge to plan advanced surveys, such as Discrete Choice Experiments with physicians

Network of physicians and experts that can be immediately engaged in our surveys

Our unique GIPAM Study Reporting (GSR): Clients get live reports on the status of our studies and – at a minimum – descriptive statistics as DAILY updates

Related Whitepaper & Publications

  • Guaranteed timelines and budgets

    We do not overpromise, and we guarantee promised timelines. If, due to us, we cannot hold the timelines we pay at least 25% of our budgets back – in all our studies, without any other restrictions. In addition, we guarantee budgets and deliverables. Based on the scope we agreed on we deliver the results, whatever it takes.

  • Intelligent & strategically meaningful

    We do not do studies that do not help our clients strategically, just for the sake of doing the study. If we are unsure about the strategic value of a study, we do a thorough strategic assessment first – before the study starts.

  • Publishable

    All our studies will be publishable in peer-review journals. Scientific protocols guide our studies – we do not generate evidence and/or recommend evidence generation that is not scientifically sound.

  • Advanced methodologies

    are part of our DNA: Whether it is an inverse probability weighting in a comparative study or latent class analyses in preference studies: we always apply the most recent and accepted methods in our studies.

  • Modern Reporting:

    We go one step forward, in each of our studies. Our GIPAM Study Reporting (GSR) provides DAILY updates through our live reporting tools: Clients see interim results seconds after they have been generated, in our primary data collections daily updated statistics about included patients & their characteristics are provided.